BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

    PMA: P920023 · Supplement: S014 · Decision Jun 7, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent
    Trade Name
    UROLUME(R) ENDOPROSTHESIS
    PMA Number
    P920023
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    MES
    Generic Name
    STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 7, 2001
    Date Received
    December 18, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A 1.5 CM STENT LENGTH, A MODIFICATION OF THE BENIGN PROSTATIC HYPERTROPHY (BPH) INDICATION, AND CORRECTION OF DELIVERY TOOL LABELING. THE DEVICE, AS MIDIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLUME(R) ENDOPROSTHESIS. THE BPH INDICATION OF THE UROLUME(R) ENDOPROSTHESIS WILL BE MODIFIED AS FOLLOWS: THE DEVICE IS INTENDED TO RELIEVE PROSTATIC OBSTRUCTION SECONDARY TO BPH IN MEN AT LEAST 60 YEARS OF AGE, OR MEN UNDER 60 YEARS OF AGE WHO ARE POOR SURGICAL CANDIDATES, AND WHOSE PROSTATES ARE AT LEAST 2.0 CM IN LENGTH.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MES Stent, Urethral, Bulbous, Permanent Or Semi-Permanent